ID

37268

Description

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Keywords

Versions (1)
  1. 7/12/19 7/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 12, 2019

DOI

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License

Creative Commons BY-NC 3.0
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HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

English

Cycle 5

1 forms  
  1. StudyEvent: ODM
    1. Cycle 5
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Local Laboratory - Haematology
Description

Local Laboratory - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Laboratory name
Description

Performing laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Performing Laboratory, Street Address

Data type

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Lab ID
Description

Laboratory Identifier

Data type

text

Alias
UMLS CUI [1]
C2986056
Date sample taken
Description

Laboratory Procedures, Hematology finding, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Planned Relative Time
Description

Laboratory Procedures, Hematology finding, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Haematology Test
Description

Laboratory Procedures, Hematology finding

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
Result
Description

Laboratory Procedures, Hematology finding, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C1274040
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Laboratory name
Description

Performing laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Address
Description

Performing Laboratory, Street Address

Data type

text

Alias
UMLS CUI [1,1]
C1882331
UMLS CUI [1,2]
C1301826
Lab ID
Description

Laboratory Identifier

Data type

text

Alias
UMLS CUI [1]
C2986056
Date sample taken
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Planned Relative Time
Description

Laboratory Procedures, Chemistry, Clinical, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Clinical Chemistry Test
Description

Laboratory Procedures, Chemistry, Clinical

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
Result
Description

Laboratory Procedures, Chemistry, Clinical, Result

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1274040
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Similar models

Cycle 5

1 forms
  1. StudyEvent: ODM
    1. Cycle 5
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing Laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Relative time, Planned
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Item
Haematology Test
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Laboratory Procedures, Hematology finding
Code List
Haematology Test
CL Item
Haemoglobin (1)
CL Item
Haematocrit (2)
CL Item
Red Blood Cell (3)
CL Item
White Blood Cell (4)
CL Item
Platelet (5)
CL Item
Neutrophils (6)
CL Item
Bands (7)
CL Item
Lymphocytes (8)
CL Item
Monocytes (9)
CL Item
Eosinophils (10)
CL Item
Basophils (11)
Laboratory Procedures, Hematology finding, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item Group
Local Laboratory - Clinical Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Performing laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Performing Laboratory, Street Address
Item
Address
text
C1882331 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
Laboratory Identifier
Item
Lab ID
text
C2986056 (UMLS CUI [1])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date sample taken
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Relative time, Planned
Item
Planned Relative Time
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Item
Clinical Chemistry Test
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Laboratory Procedures, Chemistry, Clinical
Code List
Clinical Chemistry Test
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Chloride (3)
CL Item
Bicarbonate (4)
CL Item
Calcium (5)
CL Item
Phosphorus (6)
CL Item
Magnesium (7)
CL Item
Blood Urea Nitrogen (BUN) (8)
CL Item
Urea (9)
CL Item
Uric acid (10)
CL Item
Creatinine (11)
CL Item
LDH (12)
CL Item
Aspartate Aminotransferase (AST) (13)
CL Item
Alanine Transaminase (ALT) (14)
CL Item
Bilirubin (total) (15)
CL Item
Protein (total) (16)
CL Item
Albumin (17)
CL Item
Creatinine Clearance (calculated) (18)
CL Item
CA125 (19)
Laboratory Procedures, Chemistry, Clinical, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
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